System and method for inflation syringe with improved display and modularized component assembly

ABSTRACT

An inflation syringe having an improved display and modularized component assembly. More particularly, the present invention relates to methods and apparatuses for providing both numeric and non-numeric indications of an inflation pressurization associated with an inflation syringe. A modularized component assembly for an inflation syringe allowing independent components to be tested independent of the other components of the inflation syringe.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of now pending U.S. patent applicationSer. No. 12/638,631, filed Dec. 15, 2009, entitled “System and Methodfor Inflation Syringe with Improved Display and Modularized ComponentAssembly,” which claims the benefit of priority to U.S. ProvisionalPatent Application No. 61/122,708, filed on Dec. 15, 2008, entitled“System and Method for Inflation Syringe Display and ModularizedComponent Assembly,” each of which is incorporated herein by referencein its entirety.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

Exemplary embodiments of the present invention relates to an inflationdevice that is used for controlling the inflation of a balloon-tippedcatheter. In more particular, the present invention relates to animproved inflation data display that provides an intuitive numeric andnon-numeric representation of the inflation pressurization values tofacilitate improved monitoring of balloon catheter inflation pressures.The present invention also relates to an improved modularized componentassembly system for facilitating assembly of the inflation deviceapparatus.

2. Background and Relevant Technology

Inflation syringes and catheter technologies have become increasinglyimportant in the interventional radiology and cardiology medical fields.Balloon-tipped catheter systems and inflation syringe apparatus havebeen utilized in various fields of medicine, such as urology,gynecology, cardiology and others. One area in which balloon-tippedcatheter systems and their associated syringe systems have resulted insignificant improvement over traditional treatment methods is inconnection with the treatment of coronary artery disease.

Coronary artery disease and the associated narrowing of the arteriesthat feed oxygen-rich blood to the heart (a condition known as“stenosis”) is one of the conditions for which balloon-tipped cathetersare often utilized as a method of treatment. Traditionally, coronaryartery blockages were treated with medicine or by performing coronaryartery by-pass surgery. Various kinds of medication could beadministered which would decrease the work of the heart by slowing theheart rate, dilating the blood vessels, or lowering blood pressure.However, such medicinal treatments did not cure coronary arterynarrowing. As a result, not only would the arterial narrowing remain,but it would also continue to present a risk that at some point thenarrowing would become serious enough to require surgical intervention.

In coronary artery by-pass surgery, a blood vessel from the chest or legis grafted beyond the point of blockage so that the blood detours pastthe blockage in order to reach the heart. In some severe cases, multipleby-passes are performed. As is well known, coronary artery by-passsurgery is an expensive, highly invasive procedure which often requiresprolonged hospitalization and recovery periods.

In the last several years, another method for treating coronary arterydisease has developed, called balloon coronary angioplasty, or moretechnically, percutaneous transluminal coronary angioplasty (PTCA). PTCAis a much less traumatic procedure than coronary artery by-pass surgery.PTCA takes about two hours to perform and can be conducted under localanesthesia. PTCA has significantly improved patient recovery timesallowing patients to resume normal activities in a matter of days.Because PTCA is much less expensive and less traumatic than by-passsurgery while still providing effective blockage removal, PTCA hasexperienced a dramatic increase in the number of such proceduresperformed each year.

To perform a typical PTCA procedure, an introducer sheath is insertedthrough an incision made in the groin of the patient or in the artery ofan arm of the patient. An x-ray sensitive dye is injected into thecoronary artery through a catheter that is introduced through thesheath. The dye enables the doctor, through the use of real-time x-raytechnology, to clearly view the patient's vasculature on a televisionmonitor and to thereby locate the blockage. A balloon-tipped catheter isadvanced through the vasculature to the point of the blockage with thehelp of the x-ray monitor.

Due to the increase in the number of PTCA procedures being performed,there has been a substantial increase in the use of electronicallymonitored inflation syringe systems which are utilized to inflate theballoon catheter or other inflatable balloon-type device during PTCAprocedures. Typical syringe systems comprise a barrel and a plungerwhich are selectively operable to increase fluid pressure applied to theballoon catheter and to remove the applied pressure to the ballooncatheter once the procedure is finished. The syringe systems are adaptedto provide user readable feedback to the practitioner in the form of anumeric value allowing the practitioner to assess the amount ofpressurization that is being applied to the balloon. This allows thepractitioner to closely monitor pressurization values to provide a morecontrolled and systematic inflation of the balloon during the procedure.

Many of the apparatus utilized in PTCA procedures are inexpensivedevices which can be discarded after a single use. Disposable deviceseliminate expensive and time consuming sterilization procedures whichare necessary for reusable devices. Moreover, disposable deviceseliminate the risk of transmission of diseases between patients.Consequently designers and manufacturers of inflation syringes haveworked to limit the expense of such disposable inflation syringes tomake them more cost-effective for a wide variety of applications. As aresult, there has been an emphasis in favoring simpler designs over morecomplex apparatus. Such designs typically comprise a simple digital oranalog readout of the inflation pressure on the display provided inconnection with the inflation syringes.

One typical display of electronically monitored syringes comprises a7-segment LED display having three to five fields, and perhaps a decimalpoint. Such simplistic displays are limited in the information they canconvey. Some displays provide only the current pressurization of thesyringe. Higher-end models may allow the user to toggle the display toview additional information. Although the ability to view additionalinformation can be useful, the user is required to expend mental effortand time to access the additional information, interpret the relevanceof the data, and determine how the different values interrelate. Stillmore expensive syringes may have multiple 7-segment LED displays so asto display multiple values simultaneously. Yet, even with multiplevalues displayed, a user expends time and mental effort to interpret andrelate the values, and to remember which displays represent givenvalues.

BRIEF SUMMARY OF SOME EMBODIMENTS OF THE INVENTION

The present invention relates to an inflation syringe having an improveddisplay and modularized component assembly. More particularly, thepresent invention relates to methods and apparatus for providing bothnumeric and non-numeric indications of an inflation pressurizationassociated with the inflation syringe. According to one embodiment ofthe present invention, a progressive non-numeric display is provided fordisplaying the pressurization of the inflation syringe along withnumeric indicators of the pressurization.

According to one aspect of the present invention, the progressivedisplay includes a plurality of indicia corresponding to a range ofinflation pressurization values. The indicia are actuated to exhibit agiven pressurization in a clear and intuitive manner that allows thepractitioner to: (1) easily monitor the general intensity of thepressurization; (2) intuitively track changes in the pressurization; and(3) simply observe the relationship of multiple pressurization valueswithout needing to rely solely on more time consuming and less intuitiveinterpretation of numeric displays. This permits the user to ascertainthe relationship between the current pressurization, desiredpressurization amounts, and the rate of pressurization in astraightforward and helpful manner.

According to one aspect of the present invention, the display includes anumeric display for representing the pressurization as a numeric valuein addition to the non-numeric display. This provides an additionalindication of the inflation pressurization that complements the visualindication provided by the non-numeric display. By providing the numericdisplay and the associated numeric value of the pressurization, a usercan identify more minute incremental changes to pressurization and caneasily ascertain the precise numeric value of a given pressurization.

The present invention also relates to a method of displaying non-numericindicia representing inflation pressurization. In the method, aplurality of indicia are provided to signal changes in the inflationpressurization. Once an initial pressurization is indicated, the currentpressurization and changes in pressurization can be displayed to theuser in a simple and intuitive manner. For example, one or more of theindicia can be actuated as an indication of the current pressurization.In response to a change in the pressurization, a different one of theindicia is actuated to represent the change in pressurization.

According to another aspect of the present invention, the user interfaceprovides one or more desired types of additional data such as a lastmaximum pressurization value. For example, one or more of the indiciaare identified as an indicator of a representative pressurization suchas a last maximum pressurization. Once a representative pressurizationis indicated such as by illuminating a non-numeric indicia correspondingto such representative pressurization and/or providing a blinkingnumeric indication of such representative pressurization, the currentpressurization and changes in pressurization are displayed to the userin a simple and intuitive manner. For example, once the representativepressurization is indicated, one or more of the indicia can then beactuated as a representation of the current pressurization. In responseto a change in the pressurization, a different one of the indicia isactuated to represent the change in pressurization. In one embodiment,the non-numeric indicia of current and representative pressurizationvalues can be shown together allowing the user to simply and intuitivelydetermine the relationship between the two values.

According to one aspect of the present invention, an improvedmodularized component assembly system, method and process for testingand assembly of the inflation device apparatus is provided. Themodularized component assembly enables each component of the inflationdevice to be tested while also enabling the components to be tested oncethey have been assembled together. The ability to test individualcomponents and assembled components greatly reduces or altogethereliminates the disposal of functional components or even an entireinflation syringe when a single component of the device is defective.This allows the manufacturer to test individual components separately toassess their viability. As a result, defective components can be readilyidentified before they are assembled with other components into afunctional inflation syringe.

These and other objects and features of the present disclosure willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above recited and otheradvantages and features of the invention may be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof, which areillustrated in accompanying drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are not thereforeto be considered to be limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1 is a perspective view of an inflation syringe having a displaywhich provides both numeric and non-numeric indicia to represent thepressurization of the inflation syringe;

FIG. 2 is an exploded view of the inflation syringe of FIG. 1illustrating the components of the inflation syringe and the modularizedcomponent assembly of the inflation syringe;

FIG. 3A illustrates a display of an inflation syringe comprising numericand non-numeric indicia displaying the current pressurization of theinflation syringe

FIG. 3B illustrates the display of the inflation syringe in which lastpressurization value information is displayed to a user utilizingnon-numeric indicia;

FIG. 3C illustrates the display of the inflation syringe in which lastvalue information is displayed to a user utilizing both numeric andnon-numeric indicia;

FIG. 3D illustrates the display of the inflation syringe demonstratingoperation of the display during re-pressurization of the inflationsyringe;

FIG. 4 is a flow chart illustrating of a method of displayingpressurization information utilizing numeric and non-numeric indicia;

FIG. 5A is an exploded view of the inflation syringe illustrating themodularized component assembly according to one embodiment of thepresent invention.

FIG. 5B is perspective view of the housing base and barrel of theinflation syringe illustrating the modularized component assemblyaccording to one embodiment of the present invention.

FIG. 5C is perspective view of the housing base and barrel of theinflation syringe illustrating the modularized component assemblyaccording to one embodiment of the present invention.

FIG. 6A is an exploded view of the display of the inflation syringeillustrating the modularized component assembly according to oneembodiment of the present invention.

FIG. 6B is exploded perspective view of the display of the housing baseand barrel of the inflation syringe illustrating the modularizedcomponent assembly according to one embodiment of the present invention.

FIG. 6C is perspective view of components of the housing of the displayillustrating the modularized component assembly according to oneembodiment of the present invention.

FIG. 6D is a side cut-away view of the housing of the displayillustrating the modularized component assembly according to oneembodiment of the present invention.

FIG. 6E is perspective view of components of the housing of the displayillustrating the modularized component assembly according to oneembodiment of the present invention.

FIG. 7 is a flow chart illustrating a method of testing and assemblingan inflation syringe utilizing a modularized component assembly.

DETAILED DESCRIPTION OF SOME EXEMPLARY EMBODIMENTS

The present invention relates to an inflation syringe having an improveddisplay and modularized component assembly. More particularly, thepresent invention relates to methods and apparatus for providing bothnumeric and non-numeric indications of inflation pressurizationassociated with the inflation syringe. According to one embodiment, aprogressive non-numeric display is provided for displaying thepressurization of the inflation syringe along with numeric indicators ofthe pressurization. The progressive display includes a plurality ofindicia corresponding to a range of inflation pressurization values. Theindicia are actuated to display a given pressurization and to allow thepractitioner to not only easily monitor the general intensity of thepressurization but also to monitor changes in the pressurization withoutneeding to interpret numerical values. This permits the user to quicklyascertain the relationship between the current pressurization, thedesired pressurization, and the rate of pressurization.

According to one aspect of the present disclosure, the progressivedisplay includes a numeric display for representing the pressurizationas a numeric value. This provides an additional, precise indication ofthe inflation pressurization that complements the visual indicationprovided by the non-numeric indicia. According to another aspect of thepresent invention, a user interface is provided allowing the user toinput information that can be used to automatically identify a targetpressurization or a last maximum pressurization value. The userinterface may also allow the user to select other parameters to bedisplayed.

A method of displaying a pressurization is also provided according toone aspect of the present invention. In the method, a plurality ofindicia adapted to signal changes in the inflation pressurization areprovided. One or more of the indicia are identified as an indicator of adesired pressurization such as a last maximum pressurization. Once adesired pressurization is selected, the inflation pressurization ismonitored. One or more of the indicia are actuated as an indication ofthe pressurization. In response to a change in the pressurization, adifferent one of the indicia is actuated.

An improved modularized component assembly system, and method andprocess for improving testing, assembly and the cost of the inflationdevice apparatus, are also provided according to one aspect of thepresent disclosure. In the method, the components are obtained and theneach functional component is tested separately. Once the components havebeen tested separately, the components are assembled. Consequently, inthe event that a single component is defective only the defectivecomponent will be discarded, rather than an entire inflation device.

FIG. 1 illustrates an inflation syringe 10 according to one embodimentof the present invention. Inflation syringe 10 comprises a barrel 12, aplunger 16 and a display 20. Barrel 12 includes an inner lumen which isadapted to hold a pressure transducing medium such as saline or anotherfluid. Plunger 16 is adapted to increase or decrease the pressurizationwithin barrel 12. Display 20 displays the pressurization information tothe user in a simple and intuitive manner.

In the illustrated embodiment, barrel 12 is substantially tubular inconfiguration. A syringe plunger 16 is configured to be slidably mountedwithin barrel 12. Plunger 16 includes a threaded portion 17 which isconfigured to mate with corresponding threads of a plunger retaining nut40. Plunger retaining nut 40 secures plunger 16 within barrel 12. Tubing18 is coupled to barrel 12 at one end, and to a rotatable luer coupler19 at an opposite end. Rotatable luer coupler 19 is adapted to connecttubing 18 to a balloon catheter (not depicted) or another inflatablemedical device.

The proximal end of plunger 16 is positioned within the interior ofbarrel 12 in a fluid-tight manner such that advancing plunger 16 intobarrel 12 creates positive pressure within barrel 12. The distal end ofplunger 16 comprises a handle 14 which enables a user to apply pressureto push plunger 16 further into barrel 12 or to withdraw plunger 16 frombarrel 12. The positive pressure exerted on the fluid contained withinbarrel 12 is applied to a balloon catheter through tubing 18. Tubing 18is connected to the balloon catheter by means of a rotatable luercoupler 19. Similarly, by withdrawing plunger 16 toward the rear of thebarrel 12, the positive pressure exerted on the balloon catheter may bedecreased. According to one embodiment of the present invention, theprocess of pressurizing barrel 12 to a desired pressurization and thendepressurizing barrel 12 can be considered an inflation routine.

In the illustrated embodiment, a display 20 is mounted to the exteriorof barrel 12. Display 20 provides an intuitive and easy to readconfiguration. In the illustrated embodiment, display 20 includes anumeric display 22, non-numeric display 24, and a timer display module26. By providing both a numeric display 22 and non-numeric display 24,display 20 allows a user to read and understand a wider variety ofinformation than provided by existing displays. Additionally, display 20provides pressurization information in a helpful and intuitive mannereliminating the time and mental effort required for a user to interpretthe output of existing displays. In this manner, a practitioner canfocus on other aspects of the procedure to be performed without needingto focus on interpreting individual numeric or other informationprovided by existing displays.

In the illustrated embodiment, display 20 is coupled to a pressuresensing apparatus such as a pressure transducer. The pressure sensingapparatus may be integrated within the wall of barrel 12, mounted withinbarrel 12, positioned in fluid communication with the interior of barrel12, or otherwise configured to detect the pressure inside barrel 12. Asused to describe the relationship of the pressure sensing apparatus andthe interior of barrel 12, the term “fluid communication” may includepneumatic or hydraulic transmission (direct or indirect) of fluidpressures exerted within barrel 12 and tubing 18 to the pressure sensingapparatus so that such fluid pressures can be sensed by the pressuresensing apparatus. Direct transmission of such fluid pressures can beprovided, for example, by means of a diaphragm of a piezoresistivesemiconductor transducer which is placed into contact (eitherpneumatically or hydraulically, or a combination of both) with a fluidcontained in a closed system. Indirect transmission can occur, forexample, where the transducer means is coupled to a diaphragm that inturn contacts the fluid contained in a closed system.

The pressure sensing apparatus may be coupled to display 20 on theexterior of barrel 12 so as to communicate pressurization informationassociated with the interior of barrel 12. In another embodiment, thepressure sensing apparatus may be integrated with display 20 and influid communication with the interior of barrel 12, so as to detectpressurization within barrel 12. In one embodiment, a pressure sensingapparatus is located at the end of connecting tubing attached through aT-connector to tubing 18. Alternatively, the pressure sensing apparatuscan be mounted as part of the electronic circuitry contained inside ofdisplay 20. In yet another embodiment, the pressure sensing apparatus islocated at another position remote from the barrel 12. The pressuresensing apparatus can comprise a piezoresistive semiconductor typetransducer. In still another embodiment the pressure sensing apparatusmay comprise transducer apparatus other than a piezoresistive orsemiconductor apparatus. For example, in one embodiment the pressuresensing apparatus comprises a conventional strain gauge transducer,which has been known and used in the art for many kinds of differentpressure monitoring applications, or fiberoptic transducers.

As will be appreciated by those skilled in the art, a variety of typesand definitions of inflation routines can be utilized without limitingthe scope of the invention. By way of example, and not by limitation, aninflation routine may begin when pressurization of barrel 12 begins, andcan include several instances of advancing plunger 16 within barrel 12and retracting plunger 16 from barrel 12. The inflation routine may endwhen all pressure is released from barrel 12. In another exemplaryembodiment, an inflation routine may begin when positive pressurizationis exerted within barrel 12 and ends at the conclusion of a first periodof depressurization of the barrel. In one embodiment, not all of thepressurization may be released from barrel 12 at the end of the firstperiod of depressurization. Thus, if not all pressure is released frombarrel 12, the next inflation routine may begin when an increase inpressurization is again detected, even where the pressurization is at alower value than the maximum pressurization value of the previousinflation routine. Additionally, an inflation routine may be utilizedwith a pressurization mechanism other than an inflation syringe.

As will be appreciated by those skilled in the art, the function ofinflation syringe 10 can be provided by a variety of syringe orpressurization systems, without departing from the scope and spirit ofthe present invention. In one embodiment, a pump device that ispressurized by a plunger or similarly functioning component that isactuated multiple times, and that releases the pressure through a valveis utilized instead of a barrel and plunger syringe system. In anotherembodiment an automatic pressurization device may provide the requiredpressure to a tubing and the pressure in the tubing may be detected andmonitored. A more complete description of one embodiment of a syringesystem is contained in U.S. Pat. No. 5,057,078.

FIG. 2 is an exploded view of inflation syringe 10 of FIG. 1,illustrating the components of inflation syringe 10 and the modularizedcomponent assembly of inflation syringe 10. In the illustratedembodiment, plunger 16 and handle 14 are shown separately from barrel12. Plunger 16 comprises a proximal end 30, a rubber tip 32 and threads34. The distal end of plunger 16 includes a handle receiving component38 and a spring-activated trigger 36.

In the illustrated embodiment, rubber tip 32 is positioned at proximalend 30 of plunger 16. Rubber tip 32 is adapted to engage the interior ofbarrel 12 in a fluid-tight manner to allow the user to increase thepressurization on fluid positioned within barrel 12. As the useradvances plunger 16 further into barrel 12, rubber tip 32 is alsoadvanced to increase the positive pressure within barrel 12. Similarly,the user can retract plunger 16 in a rearward direction within barrel 12to decrease the pressurization within barrel 12.

In the illustrated embodiment, plunger 16 is secured within barrel 12 byplunger retaining nut 40. The configuration of retaining nut 40 allows auser to secure plunger 16 within barrel 12 by threadably couplingretaining nut 40 to barrel securement threads 42. The configuration ofretaining nut 40 secures plunger 16 within barrel 12 while allowing forslidable movement of plunger 16 in forward and rearward directionswithin barrel 12. In the illustrated embodiment, barrel securementthreads 42 are adapted to cooperatively engage one or more additionalcomponents of inflation syringe 10. For example, barrel securementthreads 42 can be adapted to mate with a second set of correspondingthreads integrated within plunger retaining nut 40.

The distal end of plunger 16 includes a handle receiving component 38which is configured to accept and engage a spring-activated trigger 36.In the illustrated embodiment, a user can advance syringe plunger 16without engagement of threads 17 by actuating spring-activated trigger36. When the user actuates spring-activated trigger 36, a portion oftrigger 36 is retracted into handle receiving component 38. Retractingspring activated trigger 36 into handle receiving component 38disengages threads 34 from the corresponding threads of plungerretaining nut 40. As a result, plunger 16 can freely slide in either aproximal direction or distal direction within barrel 12. By releasingthe compression on trigger 36 relative to handle receiving component 38,the threads 34 are then permitted to engage the corresponding threads ofplunger retaining nut 40. Engagement between threads 34 and plungerretaining nut 40 allows plunger 24 to be advanced or retracted byscrewing plunger 16 either in a clockwise or counter clockwise directionrespectively.

Trigger 36 allows the user to rapidly provide an increase or decrease ofpressurization within barrel 12 of inflation syringe 10. In other words,a user can compress trigger 36 against handle receiving component 38 andthreadlessly advance or retract plunger 16 within barrel 12 to increaseor decrease the pressurization within barrel 12. The user can thenrelease trigger 36 and threadably advance or retract plunger 16 withinbarrel 12 to provide a more gradual adjustment of plunger 16 to a moreexacting desired pressurization. Additionally, threadably advancingplunger 16 within barrel 12 can be utilized to provide greaterpressurization within barrel 12 than can be accomplished by threadlessadvancement alone.

In the illustrated embodiment, the body of syringe barrel 12 includes amounting bracket 110. Mounting bracket 110 provides a mechanism forsecuring display 20 to syringe barrel 12. Mounting bracket 110 isintegrally coupled to the proximal, or leading end, of barrel 12. In theillustrated embodiment, mounting bracket 110 is in fluid communicationwith the interior of barrel 12 through an opening (not depicted) formedin the sidewall of barrel 12 for the purpose of communicatingpressurization information from the interior of barrel 12.

In the illustrated embodiment a display 20 is provided to relatepressurization information to a user. Display 20 includes a displaymodule 44, display circuitry 46, and a housing 48. Display circuitry 46is adapted to be coupled to display module 44. Display circuitry 46provides the pressurization and other information to be shown by displaymodule 44. Housing 48 comprises a housing base 48 b and a housing hood48 a. Housing base 48 b is adapted to receive display circuitry 46 anddisplay module 44. Housing hood 48 a can then be secured to housing baseto secure display circuitry 46 and display module 44 within housing 48.Housing hood 48 a is adapted to secure display module 44 such that it isviewable to a user.

By providing modularized components such as display module 44, displaycircuitry 46, and housing 48, in connection with display 20, amanufacturer can simply and efficiently assemble the components ofdisplay 20. Additionally, by utilizing modularized components inconnection with display 20 a manufacturer can independently test of eachcomponent of display 20, before assembly and/or attachment to a syringesystem or other inflation device. In this manner, in the event that asingle component of display 20, such as display circuitry 46, isdefective, the manufacturer can identify the defective component beforeassembly of display 20. This allows the user to discard the defectiveindividual component without discarding the entire display includingnon-defective components of display 20 and/or inflation syringe 10. Amethod of modularized component assembly is discussed more fully belowin conjunction with the discussion of FIGS. 6 and 7.

In the illustrated embodiment, display module 44 may comprise a numericindicia, non-numeric indicia, and/or a timer display module. Byproviding numeric and non-numeric indicia, a simple and intuitivedisplay of pressurization information can be provided to a user. Displaymodule 44 is an example of a means for displaying inflationpressurization information. Display circuitry 46 processes electricalsignals representing pressurization information that are output by apressure sensing apparatus. Display circuitry 46 can also control themanner in which the display module 44 displays the pressurizationinformation. Display circuitry 46 is provided as an example of a meansfor processing electrical signals from a sensor apparatus. Otherexamples of a means for processing electrical signals can include, butare not limited to, a microchip, a personal computer, and a handhelddevice such as a personal digital assistant (PDA). A method ofdisplaying pressurization information using numeric indicia andnon-numeric indicia is discussed below in conjunction with thediscussion of FIGS. 4 and 5.

According to one aspect of the present invention, display 20 may furtherinclude a pressure sensing apparatus. The pressure sensing apparatus ispositioned in fluid communication with the interior of barrel 12. In theillustrated embodiment, the pressure sensing apparatus is integratedwith display circuitry 46. Display circuitry 46 and the pressure sensingapparatus of display circuitry 46 is positioned in fluid communicationwith the interior of barrel 12.

As will be appreciated by those skilled in the art, a variety of typesand configurations of displays can be utilized without departing fromthe scope and spirit of the present invention. According to oneembodiment of the present invention, the display is provided separatelyfrom the inflation syringe. For example, the display can be provided aspart of a reusable user interface which is operably connected to adisposable inflation syringe. Other examples of means for displayinginflation pressurization can also be utilized including, but not limitedto, a cathode ray tube display, a liquid crystal display (LCD) screen, agrouping of light emitting diodes (LEDs), a handheld device such as apersonal digital assistance (PDA), and a printer for printing out a hardcopy display.

FIGS. 3A through 3D depict a display 20 having numeric and non-numericindicia for displaying pressurization information to a user in a simpleand intuitive manner according to one aspect of the present invention.With reference now to FIG. 3A, in the illustrated embodiment, display 20includes a non-numeric display 24 and numeric display 22. Non-numericdisplay 24 comprises a plurality of indicia 51. Indicia 51 areconfigured to provide a progressive display which depicts thepressurization of the inflation syringe in a simple and intuitivemanner. The progressive configuration of display and correspondingindicia 51 can provide an indication of a range of inflationpressurization values. As indicia 51 are actuated, the user can quicklyand simply determine the pressurization of the inflation syringe 10allowing the practitioner to not only easily monitor the generalintensity of the pressurization but also to monitor changes in thepressurization without needing to interpret numerical values. As aresult, the user can quickly ascertain the relationship between thecurrent pressurization, the desired pressurization, and the rate ofpressurization without needing to interpret numeric values. In oneembodiment, alternative measurements values other than pounds per squareinch (psi), such as atmospheres or bar are provided.

In the illustrated embodiment, numeric display 22 of display 20 providesa numeric indication of the pressurization in the inflation syringe.Numeric display 22 provides an additional, precise indication of theinflation pressurization that complements the visual indication providedby the non-numeric indicia 51. In the illustrated embodiment, numericdisplay 22 comprises a digital display, such as a 7-segment LED displayhaving multiple fields. As depicted, numeric display 22 includes threefields, each field representing a digit of the numeric value. Numericdisplay 22 displays a current pressurization value.

In the illustrated embodiment, display 20 may further comprise a timerdisplay module 26. Timer display module 26 provides an indication of thelength of an inflation routine, the length of time between inflationroutines, the length of time at a particular pressurization value,and/or the length of time that inflation pressure is applied to anattached inflatable medical device. Display 20 may also include a lastvalue actuation button 52. Last value actuation button 52 allows a userto toggle the numeric display 22 to display the maximum pressurizationvalue achieved during the most recent, or previous, inflation routine.

In the illustrated embodiment, an exemplary current pressurization valueof the inflation syringe is displayed as 200 pounds per square inch(psi). The numeric display 22 is configured to provide a precise,intuitive indication of a value, which typically is the currentpressurization of the interior of barrel 12. During an inflationroutine, numeric display 22 is automatically updated in real-time toprovide the practitioner with an immediate, intuitive indication of thepressurization within the interior of the barrel and/or the tubing ofthe inflation syringe. The depicted 7-segment LED display is provided asan exemplary display capable of providing a straightforward andeasy-to-read, digital display at a low cost.

As previously discussed, in the illustrated embodiment non-numericdisplay 24 includes a plurality of non-numeric indicia 51. Each ofnon-numeric indicia 51 comprises a white or colored LED. Additionally,each of the plurality of non-numeric indicia 51 of the non-numericdisplay 24 can represent one or more pressurization values. A pluralityof numeric value indicators 50 are provided in connection with indicia51 to provide a representation of the pressurization valuescorresponding to one, or a group of, non-numeric indicia 51.

In the illustrated embodiment, each indicia 51 represents a range ofpressurization values corresponding to approximately five psi. Thenumeric value indicators 50 a, b, c, d, e, f, g are spaced along theindicia 51, as shown, with a numeric value indicator corresponding withevery tenth indicia 51. As a result, the numeric value indicator 50 awhich is labeled as “0” clearly illustrates to the user than when noindicia is illuminated, or when indicia 51 a alone is illuminated, thepressurization within the inflation syringe is zero psi.

An exemplary non-numeric indicia 51 b is also depicted. In theillustrated embodiment, indicia 51 b is positioned approximately tennon-numeric indicia from indicia 51 a. A numeric value indicator 50 bwhich is labeled “50” is provided in connection with indicia 51 brepresenting a pressurization within the inflation syringe of fifty psi.As a result, when the indicia from 50 a to 50 b are illuminated, theuser can quickly and simply determine that the pressurization within theinflation syringe is fifty psi.

As will be appreciated by those skilled in the art, when thepressurization within the inflation syringe is between zero psi andfifty psi, one of the non-numeric indicia 51 positioned between indicia51 a and 51 b will be illuminated as the non-numeric representation ofthe pressurization within the inflation syringe. For example, in theevent that the pressurization within the inflation syringe is 35 psi,approximately 7 non-numeric indicia will be illuminated due to the factthat each non-numeric indicia represents a range of five psi ofpressurization. In the event that the pressurization within theinflation syringe is 45 psi, approximately 9 non-numeric indicia will beilluminated. The user can quickly ascertain the approximatepressurization within the inflation syringe by how close the lastilluminated indicia is to a particular numeric value indicator. Forexample, when the pressurization in the inflation syringe is 35 psi, theuser can quickly identify that the last illuminated non-numeric indiciais greater than zero psi, less than 50 psi. Additionally, the user canquickly identify that the last illuminated non-numeric indicia is closerto 50 psi than 0 psi. As a result, the non-numeric display 24 allows auser to quickly determine the approximate pressurization within theinflation syringe.

In the illustrated embodiment, numeric value indicator 50 c indicatesthat an indicia 51 c corresponds with a pressurization value of 100 psi.Numeric indicators 50 d through 50 g are similarly spaced, andrespectively indicate that indicia 51 d, 51 e, 51 f and 51 g representpressurization values 150 psi, 200 psi, 250 psi, and 300 psi,respectively. In the illustrated embodiment, non-numeric indicia 51 arelit in a progressive manner. Thus, all non-numeric indicia 51representing values less than the current pressurization value remainlit as the pressurization increases and additional non-numeric indicia51 are illuminated.

FIG. 3B illustrates a display 20 subsequent to previous pressurizationroutine of the inflation syringe. In the illustrated embodiment, thereis little or no pressurization within the inflation syringe. As aresult, numeric display 22 shows a pressurization of zero psi.Additionally, non-numeric indicia 51 a-51 b are not illuminated.

In the illustrated embodiment, a non-numeric indicia 51 e isilluminated. Non-numeric indicia 51 is illuminated as a representationof a value that represents something other than the currentpressurization of the inflation syringe. According to one embodiment ofthe present invention, an indicia 51, such as non-numeric indicia 51 e,can be lit to represent a last pressurization value and/or a targetpressurization value. To avoid confusion, an indicia 51 representing alast value and/or a target value may appear a different color and/orflash or blink. In the illustrated embodiment, it is fairly simple toascertain that non-numeric indicia 51 represents a last pressurizationvalue and not the current pressurization value as the indicia between 51a and 51 e are not illuminated. As will be appreciated by those skilledin the art, a non-numeric indicia can be illuminated as an indicator ofa last pressurization value while current pressurization is also beilluminated.

Display 20 may further comprise a user interface which allows a user toset a target pressurization value different from the last value. Thismay be accomplished by adjusting up or down from the displayed lastpressurization value, or by manually entering a target value. In stillanother embodiment, last value actuation button 53 can enable thetoggling of numeric display 22 between three values, currentpressurization, last value, and target value. The target value may alsobe indicated by the non-numeric display 24, either with the last valueor in place of the last value, thus giving a user a visualrepresentation of progress made in pressurizing the barrel, how muchprogress remains to reach the last value or a desired value, the rate ofpressurization, and changes in pressurization resulting from eachmovement of the plunger within the barrel. Thus, the user can moreeasily ascertain the force necessary for subsequent movements of theplunger to reach the target pressurization value. The user interface mayalso enable the user to select other parameters to be displayed.

FIG. 3C depicts display 20 of FIGS. 3A and 3B showing another manner ofdisplaying last value information to a user, immediately after the userhas pressed the last value actuation button 52. In FIG. 3B, the barrelof the inflation syringe is completely depressurized, as indicated bynumeric display 22 and non-numeric display 24. If the user wants to viewthe exact last pressurization value, this information is not readilyrepresented by indicia 51 e because of the multiple possiblepressurization values represented by each indicia 51. To view theprecise last pressurization value, the user can toggle the display bypressing last value actuation button 52. In the illustrated embodiment,the user has pressed the last value actuation button 52. Both indicia 51e of non-numeric display 24 and the 7-segment display of numeric display22 indicate the last value is 200 psi. By displaying the last valuepressurization information on non-numeric display 24 and numeric display22, precise pressurization information is provided to a user inintuitive and easy to read manner.

In one embodiment of the present invention, display 20 may automaticallytoggle to display last value information at the end of an inflationroutine. In the embodiment, display 20 will continue to display lastvalue information on both the numeric display 22 and non-numeric display24 until the beginning of the next inflation routine. At the beginningof the next inflation routine, display 20 may automatically toggle backto display current pressurization value information on numeric display22 while retaining last value information using non-numeric display 24.According to one embodiment of the present invention, the precise lastvalue information may be available by pressing last value actuationbutton 52 at any time including during or subsequent to a pressurizationroutine. Indicia 51 e may appear as a different color and/or flash toindicate it is presently representing a last value. In anotherembodiment, a user may adjust which indicia is appearing in a differentcolor and/or which indicia is flashing while setting a target valuewhich is different from the last pressurization value.

FIG. 3D illustrates display 20 during a subsequent pressurizationroutine in which the current pressurization of the inflation syringe isprovided simultaneously with the last pressurization value. In theillustrated embodiment, non-numeric indicia 51 e is illuminated as anindicator of the last pressurization value. In other words, non-numericindicia 51 e allows a user to quickly determine the maximumpressurization of the inflation syringe during the preceding inflationroutine. Because non-numeric indicia 51 e corresponds with an exemplarypressurization value of 200 psi, the user can quickly determine that amaximum pressurization of 200 psi was utilized during the previouspressurization routine. This may be helpful where a practitioner desiresto apply a similar, lesser or greater pressurization during subsequentpressurization routines. The configuration of display 20 allows a userto quickly ascertain the present pressurization value, the progress madeand remaining to reach the last value and/or the target pressurizationvalue, the rate of pressurization, and the progress made with eachmovement of the plunger, in a intuitive and simple to read manner.

In the illustrated embodiment, indicia 51 a through 51 c areilluminated. Additionally, approximately 5 additional indicia positionedbetween indicia 51 c and 51 d are illuminated. Because indicia 51 crepresents a pressurization of 100 psi, the user can quickly and simplyascertain that the pressurization in the inflation syringe represents apressurization which is greater than 100 psi. Additionally, due to thefact that indicia 51 corresponds with a pressurization of 150 psi, theuser can quickly ascertain that the current pressurization in theinflation syringes represents a pressurization that is less than 150psi. Due to the progressive nature of non-numeric indicia 51 andnon-numeric display 24, the user can visually determine that thepressurization is approximately 125 psi due to the fact that the lastilluminated non-numeric indicia 51 is positioned approximately midwaybetween 100 psi and 150 psi. This can be quickly confirmed by simplyglancing at numeric indicia 22 which confirms that the pressurization ininflation syringe is exactly 125 psi.

Providing a non-numeric display 24 in connection with a numeric display22 provides an intuitive and simple to read display while alsodisplaying more information simultaneously on the display than can bedepicted on a numeric display alone. For example, the numeric display 22can provide a current pressurization value while the non-numeric display24 simultaneously displays a current pressurization value and a lastpressurization value. In the illustrated embodiment, the user candetermine the approximate pressurization of the inflation syringeutilizing the non-numeric display 24. Additionally, the user can quicklyand easily identify the relationship between the current pressurizationand a target or last pressurization value. Additionally, the non-numericdisplay 24 can provide a visual representation of progress previouslymade in pressurizing the barrel, and of how much additionalpressurization in needed to reach a desired value, such as the lastpressurization value or a target pressurization value. For example, theuser is provided with a visual indication that the currentpressurization of 125 psi is approximately two-thirds of the lastpressurization value represented by non-numeric indicia 51 e.Additionally, the user can quickly ascertain that the currentpressurization is slightly less than half of a maximum pressurization of300 psi which corresponds with a non-numeric indicia 51 g.

Display 20 also allows a user to easily monitor the rate ofpressurization and changes in pressurization resulting from eachmovement of the plunger within the barrel. Thus, the user can morequickly estimate the force necessary for subsequent movements of theplunger to reach a desired pressurization value. In the illustratedembodiment, the arcuate or curved configuration of non-numeric display24 allows a user to determine progress along a pressurization curve. Theconfiguration of the pressurization curve provides subtle non-numericindications in addition to actual pressurization values. For example,pressurizations corresponding with the bottom portion of the curve, i.e.indicia 51 a-51 c, can quickly be identified as below typically desiredmaximum pressurization values. As the pressurization approaches the archor apex of the curve, i.e. indicia 51 d-51 f, the user can ascertainthat the pressurization is within a range of typically desired maximumpressurization values. As the user passes the apex of the curve andbegins to descend toward the final non-numeric indicia, i.e. 51 f-51 g,the user can quickly determine that the pressurization exceeds typicallydesired maximum pressurization values. In this manner, the shape of thenon-numeric indicia provides an indication of the desirability of givenpressurization values in addition to actual pressurization values.

As will be appreciated by those skilled in the art, a variety of typesand configurations of non-numeric displays can be provided withoutdeparting from the scope and spirit of the present invention. Forexample, a non-numeric display can comprise a progressive gauge or dial.In one example, the dial may be digital, comprising indicated by lights(e.g. LEDs), changing colors, notches, and/or other indicia. In anotherembodiment, rather than comprising a digital gauge or dial, non-numericdisplay may comprise an analog dial, such as an arm configured to pivotin an arc, moving along increments positioned in a curvilinear fashionon a portion of the arc. In still another embodiment, non-numericdisplay may comprise an analog gauge that displays a representation ofcurrent pressurization and progress of pressurization along a range ofpossible inflation pressures. According to one embodiment of the presentinvention, the non-numeric display may comprise indicia arranged in alinear or curvilinear array. In still another embodiment there may be aplurality of instances of non-numeric indicia, each instancerepresenting different pressurization values (e.g. currentpressurization and last value). In still another embodiment thenon-numeric indicia may be arranged in a non-linear configuration. Inthe illustrated embodiment, one side of the arcuate curve is longer thanthe other side of the curve to represent the respective desired rangesof values previously referenced.

According to an alternative embodiment of the present invention,different colors of pressurization can be provided as the pressurizationincreases along the pressure curve. For example, at low pressurization,the non-numeric indicia are illuminated green. At medium pressurization,the non-numeric indicia are illuminated yellow. At high pressurizations,the non-numeric indicia are illuminated red.

FIG. 4 is flow chart depicting a method of displaying pressurizationinformation utilizing numeric and non-numeric indicia, according to oneembodiment of the present invention. In the illustrated embodiment, themethod begins at a step 60. An inflation pressurization within theinterior of the barrel is detected in a step 62. Subsequent to detectingthe inflation pressurization, the numeric value of the pressurization isdisplayed in a step 64. The non-numeric value of the pressurization isthen displayed in a step 66. Once the numeric value of thepressurization is displayed in a step 64 and the non-numeric value ofthe pressurization is displayed in a step 66, a change in pressurizationis detected during an inflation routine in a step 68. Once the change inpressurization is detected during the inflation routine, numeric andnon-numeric changes in the pressurization values are displayed in a step70.

Subsequent to detecting of pressurization changes and display of numericand non-numeric changes in pressurization values during steps 68 and 70,a subsequent change in pressurization may be detected. In the event thata change in pressurization is detected during the inflation routine,step 68 is repeated. Once a change in pressurization is detected andstep 68 is repeated, numeric and non-numeric changes in thepressurization values are again displayed in step 70. An end of theinflation routine is detected in a step 72. Once the end of an inflationroutine is detected, non-numeric indicia corresponding to a last maximuminflation value of the previous inflation routine is displayed in a step74. Once the last maximum inflation values are displayed, in the eventthat an inflation pressurization is detected, the method returns to step62. In the event that an inflation pressurization is not detected, themethod ends in a step 76.

The detection of inflation pressurizations may be accomplished by apressure sensing apparatus, such as a pressure sensing transducer. Adisplay, such as depicted in FIGS. 3A through 3D, may display thenumeric value of the pressurization which provides a precise indicationof the pressurization value. The display may also display non-numericindicia as a representation of the value of pressurization. During theinflation routine, the pressure sensing apparatus may detectpressurization changes and then the display may update the numericindicia and non-numeric indicia to display the changes in pressurizationvalues. Detecting in step 68 and displaying in step 70 changes inpressurization values may occur multiple times during a pressurizationroutine. The method may also detect the end of the inflation routine andthen display non-numeric indicia corresponding to the last value, or themaximum value, of the inflation routine that just ended. According toone embodiment of the present invention, the method may be directed bydisplay circuitry (depicted in FIGS. 1, 2, and 6), and may beimplemented in and/or carried out wholly or partially by software and/orhardware components.

FIG. 5A is a perspective view of an inflation syringe 10 illustrating amodularized component assembly of the inflation syringe 10, according toone embodiment of the present invention. In the illustrated embodiment,display 20 comprises separate components as part of the modularizedcomponent assembly that allows for testing of the individual componentsof display 20. By testing individual components of display 20, the costof manufacturing an inflation syringe of the present disclosure can bereduced because only defective components will be discarded, rather thandiscarding an entire inflation syringe.

As discussed with reference to FIG. 2, barrel 12 may include a mountingbracket 110 to which display 20 may be attached. The mounting bracket110 further comprises a securement clip slot 124 for receivingsecurement bracket 119. Mounting bracket 110, securement bracket slot124 is an example of a means for attaching the display to a barrel of aninflation syringe. Other examples of means for attaching may include,but are not limited to a clip, hooks and loops, a pin, a detent, abutton, or other fastener device.

Display circuitry 46 and display module 44 can be tested separately,assembled, and then placed into display housing base 48 b. Displaymodule 44 can comprise numeric and non-numeric indicia to displaypressurization information. In the illustrated embodiment, displaycircuitry 46 is provided in connection with a flexible printed circuitboard 126 to aid with assembly of display 20. One or more batteries 128may also be attached to flexible printed circuit board 126 forconvenience during testing and assembly. Flexible printed circuit board126 is configured to facilitate testing of display circuitry 46 byenabling batteries 128 to power display circuitry 46 during testing.

Display module 44 can be configured to be tested separately and also tobe assembled with display circuitry 46 for further testing. Duringassembly, display circuitry 46 may be removed from flexible printedcircuit board 126 and coupled to display module 44. Batteries 128 mayalso be removed from flexible printed circuit board 126 and installed topower display circuitry 46. The assembly can then be tested togetherbefore being placed into display housing base 48 b. In anotherembodiment, flexible printed circuit board 126 can be permanentlyassembled with display circuitry 46 and display module 44. According toyet another embodiment of the present invention, flexible printedcircuit board 126 positions display circuitry 46 and batteries 128 in adesired position. Flexible printed circuit board 126 can then be removedonce additional components such as display module 44 and housing 48 areassembled.

A display housing hood 48 a is adapted to secure assembled displaymodule 44 and display circuitry 46. Housing hood 48 a is configured toreceive display module 44 and be coupled to housing base 48 b, which maybe already mounted to barrel 12. Housing hood 48 a and housing base 48 bcan then be snapped together for easy assembly. Once display 20 isattached to barrel 12, the entire assembled inflation syringe may thenbe tested. Housing 48 is an example of a means for securing a processingmeans and a displaying means to an attaching means. Other examples ofmeans for securing may include, but are not limited to a clip, hooks andloops, a pin, a detent, a button, or other fastener device.

FIG. 5B is a perspective view illustrating mounting of housing base 48 bwith barrel 12. In the illustrated embodiment, a housing base 48 b and abarrel 12 are depicted. As previously discussed, housing base 48 b isconfigured to be coupled to barrel 12 during assembly of the inflationsyringe apparatus. According to one embodiment of the present invention,housing base 48 b is coupled to barrel 12 before assembly of the othercomponents of the display 20 (see FIG. 5A). According to alternativeembodiments of the present invention, the entire housing 48 of display20 (see FIG. 5A) are assembled before coupling of housing base 48 b tobarrel 12.

In the illustrated embodiment, housing base 48 b comprises a void 112and a button receiving bore 118. Barrel 12 comprises a wall 114 and asecurement bracket slot 124. In the illustrated embodiment, a pressuresensor 116 is also depicted. During assembly, the user secures housingbase 48 to barrel 12 by positioning void 112 over mounting bracket 110of barrel 12. The user then advances housing base 48 b such that wall114 of mounting bracket 110 slides through void 112. As wall 114 ofmounting bracket 110 slides through void 112, wall 114 of mountingbracket 110 is positioned adjacent to void sidewall 113. According toone embodiment of the present invention, the close spatial relationshipbetween void sidewall 113 and wall 114 is provided to minimize lateralmovement of housing base 48 b relative to mounting bracket 110. When auser has fully advanced housing base 48 b such that housing base 48 b ispositioned adjacent to the bottom portion of mounting bracket 110,securement bracket 119 is positioned within securement bracket slot 124of mounting bracket 110. In the illustrated embodiment, securementbracket 119 comprises a post which extends a vertical distance away fromthe underside of housing base 48 b. Securement bracket slot 124comprises a cut-out positioned on the rear side of mounting bracket 110.Securement bracket slot 124 is sized to contact the lateral sideportions of securement bracket 119 such that the cooperative engagementbetween securement bracket 119 and securement bracket slot 124 minimizesor eliminates undesired movement of that housing base 48 b relative tomounting bracket 110.

In the illustrated embodiment, a pressure sensor 116 is positionedwithin mounting bracket 110. The position of mounting bracket 110 andpressure sensor 116 positions pressure sensor 116 in fluid communicationwith the interior of barrel 12. In this manner, pressure sensor 116 candirectly or indirectly monitor and relate information related to thepressurization of the fluid or air positioned within barrel 12.

Mounting bracket 110, securement clip 118, and snap fitting 112 areexamples of a means for attaching the display to a barrel of aninflation syringe. Other examples of means for attaching may include,but are not limited to a clip, hooks and loops, a pin, a detent, abutton, or other fastener device.

FIG. 5C illustrates barrel 12 and housing base 48 when housing base hasbeen securely coupled to barrel 12. As can be seen in the illustratedembodiment, when housing base 48 is secured to mounting bracket 110, abutton receiving bore 118 is positioned at the distal end of barrel 12such that a user can freely access and manipulate the button associatedwith button receiving bore 118. In this manner, a user can actuate thebutton associated with button receiving bore 118 to control or monitorvarious aspects of the inflation syringe.

In the illustrated embodiment, wall 114 of mounting bracket 110 has aslight taper such that when a user first slides mounting bracket 110through void 112 of housing base 48 b, a predetermined amount ofclearance is provided between wall 114 of mounting bracket 110 andsidewall 113 of void 112. As a user continues to advance housing base 48b in the direction of barrel 12, the clearance between wall 114 andsidewall 113 is decreased until the point in which full contact isprovided on all four lateral sides of wall 114 and void sidewall 113. Inthis manner, pressure or contact in any direction will not createinadvertent or undesired movement of housing base 48 b relative tobarrel 12.

As will be appreciated by those skilled in the art, a variety of typesand combinations of mechanisms for mounting the housing to the barrelcan be utilized without departing from the scope and spirit of thepresent invention. For example, in one embodiment, the mounting bracketis provided in connection with the housing base and a void is providedin connection with the barrel. In another embodiment, the mountingbracket has a circular or elliptical configuration and the void has acircular or elliptical configuration to mate with the shape of themounting bracket. In yet another embodiment, the pressure sensor isprovided at a location other than the mounting bracket. In yet anotherembodiment, the plurality of mounting brackets or clip-type componentsare provided to secure the housing to the barrel.

FIG. 6A is a perspective view of components of display 20 illustratingassembly of the components of display 20 according to one embodiment ofthe present invention. In the illustrated embodiment, housing 48 (seeFIG. 5A) comprises a housing hood 48 a and a housing base 48 b. Further,display 20 includes a display module 44, display circuitry 46, pressuresensor 116, flexible printed circuit board 126 a and 126 b, andbatteries 128. In the illustrated embodiment, display module 44 anddisplay circuitry 46 can be tested separately from one another before orafter coupling of display circuitry 46 to display module 44. In thismanner, in the event that one or more components of the display 20 arefaulty, the individual component can be discarded without needing todiscard the other viable and usable components of display 20. In theillustrated embodiment, display module 44, display circuit 46, andpressure sensor 116 are coupled together utilizing flexible printedcircuit board 126 a and 126 b. Additionally, in the illustratedembodiment, batteries 128 are secured to flexible printed circuit board126 a. By securing display module 44, display circuitry 46, andsecurement bracket 119 utilizing flexible printed circuit board 126,each of display module 44, display circuitry 46, and pressure sensor 116can be positioned in their desired position within housing base 48 b andhousing hood 48 a during assembly of housing hood 48 a and housing base48 b while allowing desired coupling of housing base 48 b to housinghood 48 a.

In the illustrated embodiment, housing base includes a seat 201, aretainment clip 202, a coupling mechanism component 204 a and 204 b,securement post 208 a and 208 b, and receptacle 214. Seat 201 is adaptedto receive one or both of pressure sensor 116 and display circuitry 46.In the illustrated embodiment, pressure sensor 116 is positionablewithin void 112 of housing base 48 b such that pressure sensor 116 canbe received within the mounting bracket 110 of barrel 12 (see FIG. 5B).In the illustrated embodiment, a retainment clip 202 is provided inconnection with seat 201. Retainment clip 202 is positioned such thatthe bottom edge of display circuitry 46 can be positioned beneathretainment clip 202. In this manner, the bottom edge of the displaycircuitry 46 is positioned between retainment clip 202 and the backsurface or bottom surface of housing base 48 b. Once the bottom edge ofdisplay circuitry 46 is positioned between retainment clip 202 and thebottom of housing base 48 b, the display circuitry 46 can be securedwithin housing base 48 b.

Coupling mechanism components 404 a, b are adapted to be secured tocomponents of housing hood 48 a to secure housing base to housing hood48 a. Additionally, securement posts 208 a, b are adapted to helpmaintain clearance between the walls of housing hood 48 a and housingbase 48 b while also providing a supplemental mechanism for securinghousing hood 48 a to housing base 48 b. Receptacle 214 provides an openarea within the volume provided by housing base 48 b within whichcomponents of display 20 can be positioned. In the illustratedembodiment, receptacle 214 is adapted to receive flexible printedcircuit board 126 a and batteries 128. Additionally, pressure sensor 116and display circuitry 46 can be positioned within receptacle 214.

In the illustrated embodiment, housing hood 48 a includes couplingmechanism components 206 a, b. Coupling mechanism components 206 a and206 b are adapted to be secured to coupling mechanism components 204 aand 204 b of housing base 48 b.

As will be appreciated by those skilled in the art, a variety of typesand configurations of display components can be provided withoutdeparting from the scope and spirit of the present invention. Forexample, in one embodiment, the housing hood and housing base areprovided as one integrated component. In another embodiment, housingbase is integrally coupled to housing hood. In yet another embodiment,two or more of the components, including display module 44, displaycircuitry 46, batteries 128, and flexible printed circuit boards 126 areprovided separately and are coupled together once they are positionedwithin the components of housing hood and housing base. In yet anotherembodiment, the flexible printed circuit board or other wiring orcircuitry to connect components of display 20 are integrated within thehousing hood and housing base rather than being provided separately.

FIG. 6B is a perspective of the components of housing 20 according toone embodiment of the present invention. In the illustrated embodiment,a display module 44 has been secured within housing hood 48 a.Additionally, the pressure sensor 116 has been threaded through void 112of housing base 48 b such that flexible printed circuit board 126 a, and126 b are threaded between housing base 48 b and housing hood 48 a. Inthis manner, the display module 44 can remain operably connected todisplay circuitry 46 and pressure sensor 116 while mounting displaymodule 44 within housing hood 48 a and mounting sensor 116 throughhousing base 48 b. Additionally, because batteries 128 are secured toflexible printed circuit board 126 and display circuitry 46 is operablyconnected to flexible printed circuit board 126 a and flexible printedcircuit board 126 b, display module 44 can be actuated and tested incombination with display 46 during assembly.

FIG. 6C illustrates the components of display 20 during assembly of thecomponents of display 20 according to one embodiment of the presentinvention. In this illustrated embodiment, display circuitry 46 has beenpositioned within seat 201 such that a leading edge of display circuitry46 is positioned beneath retainment clip 202. Flexible printed circuitboard 126 a has been folded such that pressure sensor 116 (not shown) ispositioned through a void 112 (not shown) of housing base 48 b. Thispositions batteries 128 in their desired position within receptacle 214of housing base 48 b. Additionally, this allows for the properpositioning of display circuitry 46 within seat 201.

According to one embodiment of the present invention, the pressuresensor 116 is positioned through void 112 (see FIG. 6B). The length offlexible printed circuit board 126 a positioned between batteries 128and pressure sensor 116 is folded such that batteries 128 are positionedfacing upward. The length of flexible printed circuit board 126positioned between batteries and display circuitry 46 is folded suchthat batteries 128 are positioned upward and display circuitry 46 ispositioned at the portion of housing base 48 b and associated with seat201. Once display circuitry 46 is positioned within seat 201, a lengthof flexible printed circuit board 126 can be slightly bended or foldedto accommodate for the shortened distance between batteries 128 anddisplay circuitry 46. In other words, as display circuitry 46 ispositioned beneath retainment clip 202, the displacement betweenbatteries 128 and displace circuitry 46 is lessened. The configurationof flexible printed circuit board 126 a allows for subtle folding orother manipulation needed to accommodate for such changes in thejuxtaposition of display circuitry 46 and batteries 128.

In the illustrated embodiment, display module is secured within housinghood 48 a. Flexible printed circuit board 126 b is secured to displaymodule 44 and display circuitry 46. The length of flexible printedcircuit board 126 b allows for a desired separation between both housinghood 48 a and housing base 48 b while maintaining the connection betweendisplay module 44 and display circuitry 46. In this manner, when displaymodule 44 is positioned within housing hood 48 and display circuitry 46is positioned within housing base 48 b, the components can remainoperably connected to one another while also allowing ongoing assemblyof the components. In the illustrated embodiment, the coupling providedby flexible printed circuit board 126 b also allows for testing ofdisplay circuitry 46 and display module 44 while operably connected toone another before final assembly of all the components of display 20.When a user desires to finalize assembly of housing hood 48 a andhousing base 48 b, flexible printed circuit board 126 b can be foldedsuch that flexible printed circuit board 126 b is positioned betweenbatteries 128 and display module 44 in a sandwich configuration whilebeing entirely positioned within housing hood 48 a and housing base 48b. This provides both improved testing of the components of the display20 while also allowing for improved reliability and efficiency ofmanufacture of the components of display 20.

It will be appreciated by those skilled in the art that a variety oftypes and configurations of securement of the components of display 20can be utilized without departing from the scope and spirit of thepresent invention. For example, according to one embodiment of thepresent invention, a single length of flexible printed circuit board canbe utilized to secure two or more components of the display. Accordingto another embodiment, the batteries are secured to the other componentsof the display without utilizing flexible printed circuit board.According to yet another embodiment of the present invention, one ormore components of the display are operably secured to one another whenthe housing hood is secured to the housing base.

FIG. 6D is a side cross-sectional view of display 20 illustrating thejuxtaposition of housing hood 48 a and housing base 48 b after assemblyof an inflation syringe. In the illustrated embodiment, housing base 48b is secured to housing hood 48 a securing the position of displaycircuitry 46 within housing 48. In the illustrated embodiment, housingbase is secured to housing hood by the securement of coupling mechanismcomponents 204 a, b to coupling mechanism components 206 a, b. Couplingmechanism components 204 a, b are associated with housing base 48 b.Coupling mechanism components 206 a, b are associated with housing hood48 a. Additionally, according to one embodiment of the presentinvention, securement posts 208 a, b are utilized to secure housing hood48 a to housing base 48 b. In the illustrated embodiment, display module44, pressure sensor 116, flexible printed circuit board 126 a andflexible printed circuit board 126 b are not shown. However, aspreviously discussed, the display module, pressure sensor, and flexibleprinted circuit boards are adapted to be operably connected withinhousing hood 48 a and housing base 48 b.

FIG. 6E is a perspective view illustrating housing hood 48 a and housingbase 48 b when housing hood 48 a is secured to housing base 48 b. In theillustrated embodiment, no display module is shown within housing hood48 a for the purpose of illustrating the juxtaposition of the housinghood, 48 a, housing base 48 b and display circuitry 46. In this manner,the user can observe the manner in which display circuitry 46 is securedutilizing retainment clip 202. In the illustrated embodiment, clip 202is positioned adjacent void 112 in housing base 48 b. A user advancesdisplay circuitry 46 such that a leading edge of display circuitry 46 ispositioned beneath retainment clip 202. Once display circuitry 46 ispositioned relative to retainment clip 202, display circuitry 46 can besecured within housing base 48 b. In one embodiment, display circuitry46 is secured within seat 201 by the cooperative engagement of housinghood 48 a and housing base 48 b. According to another embodiment of thepresent invention, the components of housing base 48 b alone securedisplay circuitry 46. In another embodiment, once display circuitry 46is positioned relative to retainment clip 202, display circuitry iswelded, glued, or otherwise secured mechanically to housing base 48 b.In the illustrating embodiment, display circuitry 46 is positioned at anangle within housing base 48 b by being positioned at a sloped anglerelative to the other components of housing base 48 b. Flexible printedcircuit board, batteries, or other components to be positioned withinreceptacle 214 of housing base 48 b can be positioned in a desiredmanner without impedance from or interference to display circuitry 46.

As will be appreciated by those skilled in the art, a variety of typesand configurations of housings can be provided without departing fromthe scope and spirit of the present invention. For example, in oneembodiment of the present invention, a mechanism other than a retainmentclip is utilized to secure the display circuitry. In another embodiment,the display circuitry is positioned within its own receptacle to protectit from damage from the other components of the display. In yet anotherembodiment, the display circuitry is positioned away from the void ofthe housing base to protect the display circuitry from the externalenvironment.

Modularized component assembly, and testing of individual and assembledcomponents during the assembly, enable identification of defectivecomponents. Consequently, significant cost reduction may be achievedsimply by discarding only defective components rather than discardingentire inflation syringes which may include several inflation syringecomponents which are not defective.

FIG. 7 is a flow chart illustrating a method of testing and assemblingan inflation syringe utilizing a modularized component assembly,according to one embodiment of the present invention. The method beginsat a step 130. The components of the inflation syringe are obtained in astep 132. Once the components of the inflation syringe are obtained, theintegrity of the inflation syringe barrel is tested in a step 134. Theoperation of the display circuitry is then tested in a step 134. Oncethe operation of the display circuitry is tested, the operation of thedisplay module is tested in a step 138.

The housing base is then secured to the mounting bracket of theinflation syringe in a step 140. Once the housing base is secured to themounting bracket, the display module and circuitry are assembled in astep 142. The display module and circuitry are placed in the housingbase in a step 144. Once the display module and circuitry are placed inthe housing base, the housing hood is coupled to the housing base tosecure the display module and circuitry to the inflation syringe in astep 146. The assembled inflation syringe including the assembleddisplay then undergoes final testing in a step 148. Once the assembledinflation syringe has undergone final testing, the method is ended in astep 150.

According to one embodiment of the present invention, the preassembledcomponents may include, but are not limited to, a pre-assembled syringesystem comprising a barrel and plunger, a display housing comprising abase and a hood, a display module, and display circuitry. In anotherembodiment, a tubing may be pre-connected to the barrel with the tubingbeing adapted to connect to an inflatable medical device. Each of thecomponents of the inflation syringe may be tested separately. The methodmay test the integrity of the syringe system, including the barrel andplunger and any other syringe system components to ensure a fluid tightseal and to ensure that the barrel can be pressurized and holdpressurization. According to one embodiment of the present invention,the testing method is adapted to test operation of the display circuitryand test operation of the display module, including testing of both thenumeric and non-numeric indicia.

After verifying that the components of the inflation syringe functionproperly, modularized assembly may begin by securing the housing base tothe mounting bracket of the inflation syringe barrel. The display moduleand display circuitry may then be assembled and tested together beforebeing installed. If the display module and display circuitry properlyfunction when assembled, the assembly may be placed in the displayhousing base. The display module and display circuitry may be secured bycoupling the housing hood to the housing base. When the display attachedto the syringe barrel, the fully assembled inflation syringe can betested.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope. Note that elements recitedin means-plus-function format are intended to be construed in accordancewith 35 U.S.C. §112 ¶6.

1. A method of assembling a modularized component assembly of aninflation syringe, the method comprising: obtaining a syringe systemcomprising a barrel; testing the integrity of the syringe system;obtaining a processor adapted to process signals from a pressure sensingapparatus; testing operation of the processor; obtaining a displaymodule adapted to display information communicated in the signalsreceived from the pressure sensing apparatus and processed by theprocessor numeric and non-numeric; testing operation of the displaymodule; securing a housing base to a mounting point on the barrel;coupling the processor to the display module; testing the processor anddisplay module coupled together; placing the processor and displaymodule in the housing base, wherein the processor is positioned toreceive signals from a pressure sensing apparatus that detectspressurization within the barrel; coupling a housing hood to the housingbase, wherein the housing hood is adapted to secure the processor anddisplay module; and testing operation of the fully assembled inflationsyringe.
 2. The method of claim 1, wherein in the event that operationof one component of the inflation syringe is faulty, the faultycomponent can be discarded and replaced with a new component withouthaving to discard of any other component of the inflation syringe. 3.The method of claim 2, further comprising the steps of detecting that aparticular component is not operating correctly.
 4. The method of claim3, further comprising the steps of discarding the component that is notoperating correctly.
 5. The method of claim 4, further comprising thesteps of replacing the component that is not operating correctly with anew component.
 6. The method of claim 5, further comprising the testingthe new component to determine if it is operating correctly.